Kornimate/medical-research-clean huggingface dataset:
short course low dose oral colchicine after st elevation myocardial infarction(stemi)

Conditions: STEMI

Summary: to study efficacy and safety oral colchicine 0.6 mg post st elevation myocardial infraction (stemi)

colchicine is a cheap and potent anti-inflammatory. we believe anti-inflammatory is able to reduce inflammation in coronary arteries and heart muscle post st elevation myocardial infarction which may benefit in short and long term outcome in patients. the short term outcome is measured using serum troponin and long term outcome is assessed with transthoracic echocardiogram and major adverse cardiac events.

Eligibility criteria:
inclusion criteria: 1. age between 18 years to 80 years old 2. stemi within 24 hours of admission to pusat perubatan ukm \& undergoing revascularization therapy (percutaneous coronary intervention) during admission stemi is diagnosed when there is: * st elevation of ≥1 mm in 2 contiguous leads or * a new onset lbbb in the resting ecg * in a patient with ischaemic type chest pains of \> 30 minutes and * accompanied by a rise and fall in cardiac biomarkers (cpg malaysia stemi 2019, 4th edition) exclusion criteria: 1. pre-existing severe heart failure with left ventricular ejection fraction less than 35% 2. clinically unstable (intubated or double inotropic support) 3. refuse or not suitable for cardiac revascularization therapy 4. anaemia induced angina (hb \< 9 g/dl) 5. ongoing sepsis requiring antibiotic 6. ongoing diarrhea (loose stool 3 times or more per day - stool consistency bristol chart type 6 \& 7) 7. active covid-19 infection (\< 7 days for category 1-3, \< 10 days for category 4-5) 8. stroke within previous 3 months 9. coronary bypass surgery either within the previous 3 years or planned 10. active malignancy or treated malignancy within 7 years 11. active inflammatory bowel disease on treatment 12. active neuromuscular disease on treatment 13. chronic kidney disease (ckd stage 4 - egfr \< 30 ml/min/1.73 m2) 14. severe hepatic disease (alt \> 3x upper limit normal, bilirubin \> 2x upper limit normal) 15. active drug or alcohol abuse on therapy 16. on long term or recent systemic glucocorticoid therapy within 3 months 17. pregnancy or breastfeeding 18. known sensitivity to colchicine or multivitamin tablet 19. pre-existing indication for colchicine therapy (gout, familial mediterranean fever, etc) 20. patients on oral medications that may interact with colchicine (clarithromycin, ketoconazole, voriconazole, fluconazole, itraconazole, cyclosporine, ritonavir)
a study to assess the safe-use conditions for administration of zulresso® in a home setting

Conditions: Postpartum Depression

Summary: the primary purpose of this study was to evaluate whether the safe-use conditions for administration of brexanolone (zulresso®) can be implemented in a home setting.


Eligibility criteria:
inclusion criteria: 1. ambulatory female ≥18 years of age. 2. participant has a current diagnosis of postpartum depression (ppd), as confirmed by the investigator. 3. participant agrees not to be the primary caregiver of any dependents during the infusion and must be accompanied by another adult (other than the home healthcare provider) during interactions with their child(ren). 4. participant has no history of sleep apnea or any clinically significant respiratory conditions. 5. participant agrees to refrain from the use of central nervous system depressants, such as opioids, benzodiazepines, sleep aids and from drinking alcohol during the infusion. 6. participant is suitable for administration of zulresso® in a home setting, as per the judgement of the investigator. 7. participant's home is suitable and has necessary provisions for administration of zulresso® and meets the following criteria: * safe environment for the home infusion provider staff. * access to a working telephone. * electricity and grounded electrical outlets. * running water. * access to back-up emergency services (911 service or ambulance availability). * sanitary environment. 8. participant agrees to stay at home until the end-of-study visit has been completed, except for a medical emergency. 9. participant must have a negative pregnancy test at screening and on day 1 prior to the start of the zulresso® infusion. exclusion criteria: 1. participant has end stage renal failure. 2. participant has known allergy to progesterone or allopregnanolone or any excipients in the brexanolone injection. 3. participant is currently at risk of suicide, as judged by the investigator, or has attempted suicide associated with the current episode of ppd.
does botulinum toxin injections improve outdoor activity in children with cerebral palsy?- a pilot study

Conditions: Cerebral Palsy

Summary: background: motor impairment limits social and recreational activities in children with cerebral palsy (cp), compromising participation and impacting on quality of life. improvement of motor function by medical treatment may advance in participation of outdoor activities and expand social and recreational activities. while botulinum toxin (btx) injections are effective and safe treatment for spasticity in children with cp, there is insufficient evidence for improvement of motor function and enhanced participation in this population. objective: to examine outdoor activity as a functional outcome following lower limb btx in children with cp. methods: in this pilot study the investigators will use global positioning systems (gps) to measure walking speed, distances, number of walking events and destinations in ambulatory children with cp following btx injection to the lower limbs; age and gender matched sibling will be studied as a control group. outdoor activity will be measured at 1, 3 and 6 months following btx treatment will be compared to baseline and to those of siblings. outdoor activity will be correlated with leisure activity preferences and quality of life questionnaires. significance: improvement in outdoor activity following btx injections in this pilot study will assist construction of a larger study evaluating participation and quality of life in children with cp.


Eligibility criteria:
inclusion criteria: * ambulatory children with cp following btx injection to the lower limbs exclusion criteria: * significant psychomotor retardation, psychiatric symptoms or behavioral problem that may impact on outdoor activity prefernces

Keywords: functional outcome quality of life global positioning system (gps) advanced tracking technologies time-space activity. walking speed distances number of walking events and destinations
comparing bupivacaine, lidocaine, and a combination of bupivacaine and lidocaine for labor epidural activation

Conditions: Labor Pain

Summary: this study will compare and determine the most ideal local anesthetic (la) solution to activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus lidocaine.

the most common and effective method for controlling labor pains is a local anesthetic (la) infusion through a lumbar epidural. to achieve adequate pain control during the first stage of labor - onset of contractions to complete cervical dilation - nerve fibers up to the t10 dermatome must be anesthetized. when a patient is in active labor and an epidural catheter is placed, the anesthesiologist must activate the epidural by administering la through the epidural to promote spread of the la in the epidural space to anesthetize the nerve fibers involved in the conduction of labor pains. the ideal la to achieve this goal is one that would allow for the fastest onset to achieve quick pain relief with the fewest side effects. two commonly used la to provide labor analgesia are bupivacaine and lidocaine. when low concentrations - 0.25% bupivacaine and 1% lidocaine - are used for labor analgesia, both of these la can be administered safely with very little concern of major adverse effects associated with la toxicity. given that there is limited and conflicting evidence for the usefulness of the bupivacaine and lidocaine mixture especially as it relates to labor epidural activation, we hope to readdress these questions in an effort to determine whether or not the la combination offers any distinct advantage over the individual la. the investigators intend to determine the time it takes to achieve an adequate level (t10) for labor analgesia, the total spread of local anesthetic, and the degree of motor block as these factors will be important in determining the most optimal la solution to activate a labor epidural. with the results from this study, the investigators hope to recommend a la solution that will allow for the fastest pain relief in the laboring mother with the fewest side effects.

Eligibility criteria:
inclusion criteria: * pregnant patients over the age of 19 who are scheduled for an induction of labor and request an epidural are eligible for the study exclusion criteria: * age \<19 * allergy to the drug or drug class * preexisting neuropathy * history of back pain prior to pregnancy or history of back surgery * history of chronic opioid use * history of hypertension or hypertensive disorders of pregnancy * congenital or acquired cardiac disease * contraindication to epidural placement (patient refusal, severe coagulopathy, infection at site of epidural needle insertion, severe hypovolemia)

Keywords: local anesthetic labor epidural
a study run at multiple study sites to test whether the samanta questionnaire that is used to diagnose heavy menstrual bleeding (hmb), can also be used to assess changes of severity of hmb in women with hmb who are treated during 12 months with a chronic hormonal treatment

Conditions: Menorrhagia

Summary: a study run at multiple study sites in spain to test whether the samanta questionnaire that is used to diagnose heavy menstrual bleeding (hmb), can also be used to assess changes of severity of hmb in women with hmb who are treated during 12 months with a chronic hormonal treatment. patients that are treated with chronic hormonal treatment as levonorgestrel (trade name mirena) or with a combination of estradiol valerate and dienogest (trade name qlaira) or with medroxyprogesterone acetate (trade name progevera) and any new hormonal treatment marketed in spain that has the indication for hmb in routine gynaecological practice are observed for 12 months in this study or for a shorter period in time in case of withdrawal. the study aims also to describe the overall satisfaction of women with their chronic hormonal treatment for hmb and how the women think their menstrual bleeding has changed. in addition the study aims to describe the changes of the score that is derived from the samanta questionnaire in relation to quality of life. quality of life is measured with the sf36v2 questionnaire. the short form (36) health survey is a 36-item, patient-reported survey of patient health.


Eligibility criteria:
inclusion criteria: * women in childbearing age, ≥18 years old, not intending to become pregnant during the next year. * women diagnosed with heavy menstrual bleeding or idiopathic menorrhagia according to medical criteria and based on clinical judgment. * women for whom the clinician decides, in agreement with the patient, to prescribe any of the available chronic hormonal treatments with the therapeutic indication of hmb in spain (mirena, qlaira or progevera). * women capable of reading and writing. * women who signed the informed consent. exclusion criteria: * women with amenorrhea or menopause. * women with contraindications and warnings with the chronic hormonal treatment prescribed for hmb as per the summary of product characteristics (interaction with concomitant medication, etc.). * women receiving contraceptive hormonal therapy or using a copper intrauterine device. * women on hormone replacement therapy. * women with a history of malignancy. * women with degenerative diseases that could directly negatively impact their daily life. * women who have given birth within the previous 6 months. * women who are pregnant. * women participating in an investigational program with interventions outside of routine clinical practice. * women with psychiatric disorders who are unable to make decisions and follow instructions. * women with concomitant medication that may lead to changes in the bleeding pattern (e.g. antiplatelet and/ or anticoagulants).

Keywords: heavy menstrual bleeding
simultaneous integrated boost in malignant glioma patients treated with chemoradiation

Conditions: Glioblastoma Multiforme; Chemoradiation

Summary: simultaneous integrated boost (sib), a field-in-field escalation technique, has been introduced to deliver higher radiation dose to the certain part of target with the same fractionation scheme. the aim of this study was to investigate the value of chemoradiation (ccrt) using sib in glioblastoma and the correlation with surgical extent.

the sib technique provides the higher radiobiological effect with the same fractionation scheme, i.e. 69 gy over 6 weeks, which might increase the loco-regional control. besides, the co-registration with magnetic resonance imaging (mri) strengthens the precision of target delineation as well as higher possibility to spare adjacent normal brain tissue. in this protocol, the newly diagnosed, primary glioblastoma patients received sib 69 gy/30 fractions to preoperative tumor bed and surgical cavity, while 60 gy/30 fractions were covering preoperatively edematous area. to determine the status of surgical extent, postoperative ct scan and mri was acquired within 72 hours and at 4th week after surgery. during the period of chemoradiation, acute neurotoxicity and hematological toxicity was assessed as well.

Eligibility criteria:
inclusion criteria: * age 18 years or above * newly diagnosed, tissue-proven glioblastoma * pre-radiotherapy karnofsky performance score (kps) ≧60. exclusion criteria: * any previous history of chemotherapy or radiotherapy * receiver of any investigating agents * recurrent gbm * any second malignancies.

Keywords: glioblastoma chemoradiation simultaneous integrated boost
assessment of the validity, reliability, and feasibility of two smartphone applications for testing the visual acuity

Conditions: Vision Impairment; Blindness

Summary: visual acuity (va) is the most common measure of visual function globally. in clinical settings and during screening events, va is an important measure to quantify changes in vision over time. additionally, in the context of epidemiological studies and population-based surveys, va is a critical measure to determine the presence and degree of vision impairment and to report on the indicators of effective eye care service coverage (i.e. refractive error and cataract surgery), that are currently considered by world health organization (who) for monitoring progress towards the universal health coverage. there are numerous applications for assessing va; however, the number of validated applications is limited. in this study, the investigators aim to evaluate the external validity, intra- and inter-observer reliability, and feasibility of two applications ("easy vision" and "peek acuity") for testing the visual acuity.


Eligibility criteria:
inclusion criteria: • age ≥10 years old exclusion criteria: • subjects who are not able to respond to the examiner

Keywords: visual acuity smartphone
validating 4ts for heparin induced thrombocytopenia (hit)

Conditions: Heparin-Induced Thrombocytopenia

Summary: the purpose of this study is to evaluate a scoring tool to help determine the presence of heparin induced thrombocytopenia (hit), which is an adverse reaction to heparin. we hypothesize that this scoring tool will be very useful in excluding patients who are suspected of having hit.

hit is an immune response to heparin that can result in thrombogenic thrombocytopenia. it is often a difficult diagnosis to make, and its diagnosis is dependent upon both clinical and serologic criteria. due to this ambiguity, increased testing and treatment may occur until serologic test results return. recently, scoring tools have been developed to assist with the diagnosis of this disease. however, these scoring tools have yet to be validated. thus, we plan to conduct a prospective, observational study to validate two scoring tools, the 4ts and the chong scale, in the diagnosis of hit. in order to validate these scoring tools, two physicians will independently score the 4ts and the chong scale for all patients suspected of having hit. these patients will be identified if a physician has ordered hit antibody testing using the enzyme immunoassay (eia) method. confirmatory testing with a serotonin release assay (sra) will also be performed.

Eligibility criteria:
inclusion criteria: * patients with suspected hit. exclusion criteria: * none.

Keywords: heparin-induced thrombocytopenia hit 4ts chong scale interobserver variability
lenvatinib plus pd-1 antibody for unresectable icc

Conditions: Intrahepatic Cholangiocarcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with pd-1 antibody for patients with unresectable intrahepatic cholangiocarcinoma.


Eligibility criteria:
inclusion criteria: * the diagnosis of icc * patients must have at least one tumor lesion that can be accurately measured according to mrecist criteria. * chemotherapy resistance or patient refuse chemotherapy * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * without distant metastasis, but intrahepatic lymph node metastasis is allowed * the following laboratory parameters: platelet count ≥ 50,000/μl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 32 g/l asl and ast ≤ 6 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: intrahepatic cholangiocarcinoma lenvatinib pd-1 antibody
3d comparison of anterior teeth retraction and anchorage control between en-masse and two-step mechanics

Conditions: Malocclusion, Angle Class I; Bimaxillary Protrusion; Orthodontic Space Closure

Summary: the aim of this study is to compare en masse (em) and two-step anterior teeth retraction (tsr) evaluated by means of three-dimensional images superimposition. thirty-two adult patients with bimaxillary protrusion planed for treatment with four first premolar extractions will be enrolled. all patients will be randomly allocated in a 1:1 ratio to either em (n=16) group or the tsr (n=16) group. cone bean computed tomography will be taken before and after anterior retraction. a blind observer will construct separate 3d models for maxillary and mandibular surfaces using the anterior cranial fossa to register models of before and after space closing. quantitative assessment of posterior anchorage loss and amount of anterior teeth retraction are the main outcomes. the secondary outcomes are the inclination of the molars, canines and incisors.


Eligibility criteria:
inclusion criteria: * angle class i malocclusion; * bimaxillary protrusion; * convex profile; * all natural teeth present in the mouth; * absence of crowding or with negative discrepancy up to 4mm; * absence of vertical and transverse occlusal problems; * good oral health; * good general health. exclusion criteria: * lack of time to attend consultations; * patients with severe systemic and psychological illness; * patients with parafunction (bruxism), reflux or eating disorders; * presence of periodontal disease;
biological collection of neurocognitive disorders

Conditions: Neurocognitive Disorders

Summary: the development of biological biomarkers reflecting neuropathology has enhanced the diagnostic precision of alzheimer's disease over the past decade, compared to the clinical diagnosis that suffers from low specificity. patients undergoing evaluation in specialized memory clinics suspected of major or minor neurocognitive disorder are notably examined through a lumbar puncture to measure beta-amyloid 42, beta-amyloid 40, total tau, and phosphorylated tau in the cerebrospinal fluid (csf). the purpose of this clinico-biological collection is to better characterize the existing biomarkers used in clinical practice, as well as the development of new diagnostic or prognostic biomarkers for neurodegenerative diseases causing neurocognitive disorder (alzheimer's disease, lewy body disease, frontotemporal lobar degeneration, in particular). the primary objective is to gain a better understanding of conventional biomarkers and to develop new diagnostic and prognostic biomarkers for neurocognitive diseases: establishing a prospective clinico-biological collection of patients evaluated in clinical practice for a neurocognitive disorder.


Eligibility criteria:
inclusion criteria: * adult patient * not under legal guardianship * clinical indication for blood and cerebrospinal fluid (csf) biomarkers measurement during a day hospital stay for alzheimer's disease (beta-amyloid peptide, tau protein). * signature of the research consent form. exclusion criteria: * not affiliated with a social security scheme. * patient under state medical aid (ame).
aspergillus-specific pcr assay in cerebrospinal fluid samples for detection of central nervous system aspergillosis

Conditions: Aspergillosis; Infection in an Immunocompromised Host

Summary: central nervous system (cns) invasive aspergillosis (ia) is a fatal complication in immunocompromised patients. confirming the diagnosis is rarely accomplished as invasive procedures are hampered by neutropenia and low platelet count. cerebrospinal fluid (csf) cultures or galactomannan (gm) regularly yield negative results thus suggesting the need for improving diagnostics. therefore the performance of an established aspergillus-specific nested pcr in csf samples of immunocompromised patients with suspicion of cns ia will be evaluated.

central nervous system (cns) invasive aspergillosis (ia) is a fatal complication in immunocompromised patients with hematological malignancies. confirming the diagnosis is rarely accomplished as invasive procedures are impaired by neutropenia and low platelet count. cerebrospinal fluid (csf) cultures or galactomannan (gm) regularly yield negative results thus suggesting the need for improving diagnostic tools. therefore the performance of an established aspergillus-specific nested pcr assay in csf samples of immunocompromised patients with suspicion of cns ia will be evaluated.

Eligibility criteria:
inclusion criteria: * immunocompromised patients with suspected cns infection, especially cerebral aspergillosis exclusion criteria: * proven cns infections caused by pathogens other than aspergillus